药物持续性以及通用名和品牌名降压药物的使用
Medication persistence and the use of generic and brand-name blood pressure-lowering agents.
作者信息
Corrao Giovanni, Soranna Davide, La Vecchia Carlo, Catapano Alberico, Agabiti-Rosei Enrico, Gensini Gianfranco, Merlino Luca, Mancia Giuseppe
机构信息
aDepartment of Statistics and Quantitative Methods, Unit of Biostatistics, Epidemiology and Public Health, University of Milano-Bicocca bDepartment of Epidemiology, Istituto di Ricerche Farmacologiche 'Mario Negri' cDepartment of Clinical Sciences and Community Health, University of Milano, Milan, Italy dInternational Prevention Research Institute (IPRI), Lyon, France eDepartment of Pharmacological Sciences fCentre for Pharmacoepidemiology and Pharmacoutilization, University of Milano, Milan gDepartment of Clinical and Experimental Sciences, University of Brescia, Brescia hDepartment of Experimental and Clinical Medicine, University of Firenze, Firenze iOperative Unit of Territorial Health Services, Region Lombardia jIRCCS, Istituto Auxologico Italiano kCentre for Clinical Physiology and Hypertension, University of Milano-Bicocca, Milan, Italy.
出版信息
J Hypertens. 2014 May;32(5):1146-53; discussion 1153. doi: 10.1097/HJH.0000000000000130.
BACKGROUND
Because of their lower cost, healthcare systems recommend physicians to prefer generic products, rather than brand-name medicaments. There is then considerable interest and debate concerning safety and effectiveness of generic products. Few studies have compared patients treated with brand-name and generic drugs for adherence to treatment, with somewhat inconsistent results. The primary objective of this study was to compare the risk of discontinuing antihypertensive drug therapy in patients treated with generic or brand-name agents.
METHODS
The 101,618 beneficiaries of the Healthcare system of Lombardy, Italy, aged 18 years or older who were newly treated on monotherapy with antihypertensive generic or brand-name drugs during 2008, were followed until the earliest date among those of the occurrence of treatment discontinuation to whatever antihypertensive drug therapy (outcome), or censoring (death, emigration, 12 months after treatment initiation). Hazard ratios of discontinuation associated with starting on generic or brand-name products (intention-to-treat analysis), and incidence rate ratio of discontinuation during periods on generic and brand-name products (as-treated analysis) were respectively estimated from a cohort and self-controlled case series analyses.
RESULTS
Patients who started on generics did not experience a different risk of discontinuation compared with those starting on brand-name agents (hazard ratio: 1.00; 95% confidence interval 0.98-1.02). Discontinuation did not occur with different rates during periods covered by generics or brand-name agents (incidence rate ratio: 1.01; 95% confidence interval 0.96-1.11) within the same individuals. A number of sensitivity and subgroup analyses confirmed the robustness of these findings.
CONCLUSION
Generic products are not responsible for the high rate of discontinuation from antihypertensive drug therapy. Assuming therapeutic equivalence, clinical implication is of prescribing generic drug therapies.
背景
由于成本较低，医疗保健系统建议医生优先选择通用产品，而非品牌药物。因此，关于通用产品的安全性和有效性存在相当大的关注和争议。很少有研究比较使用品牌药和通用药物治疗的患者的治疗依从性，结果有些不一致。本研究的主要目的是比较使用通用或品牌药物治疗的患者停用抗高血压药物治疗的风险。
方法
对意大利伦巴第医疗保健系统的101618名18岁及以上的受益人进行了随访，这些受益人在2008年开始接受抗高血压通用或品牌药物单药治疗，随访至出现任何抗高血压药物治疗停药（结局）或审查（死亡、移民、治疗开始后12个月）的最早日期。分别通过队列分析和自我对照病例系列分析，估计开始使用通用或品牌产品的停药风险比（意向性分析），以及在使用通用和品牌产品期间的停药发病率比（实际治疗分析）。
结果
开始使用通用药物的患者与开始使用品牌药物的患者相比，停药风险没有差异（风险比：1.00；95%置信区间0.98 - 1.02）。在同一患者中，通用或品牌药物治疗期间停药发生率没有差异（发病率比：1.01；95%置信区间0.96 - 1.11）。多项敏感性和亚组分析证实了这些发现的稳健性。
结论
通用产品并非导致抗高血压药物治疗停药率高的原因。假设治疗等效性，临床意义在于开具通用药物治疗处方。
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